Identity
- Trade Name
- DenSureFit FDA UDI
- Generic Name
- Denture reliner, soft, home-use FDA UDI
- Device Name
- DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen. FDA UDI
- Model / Reference
- DSF212.00 FDA UDI
- Description
- DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863995000109 FDA UDI
- FDA Product Code
- EBP FDA UDI
- GMDN Term
- Denture reliner, soft, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture reliner, soft, home-use
DenSureFit by Otc Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Denture reliner, soft, home-use.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Otc Dental
Sources (1)
- FDA UDI 9d894725-2763-41d0-81e4-8ccbce6758e3 33 fields · synced May 30, 2026